This Guidance is intended to provide Harvard faculty who conduct clinical research and those who administer and oversee research projects uniform criteria for the conduct of research with a clinical care component.
Because Harvard does not have a teaching hospital, providing clinical care is outside the mission of the University (the exception being the teaching clinic at the Dental School). With no teaching hospital, Harvard lacks the administrative infrastructure that hospitals have to comply with regulations that apply to clinical care – the treatment of patients. Clinical research, on the other hand, is supported across the University.
The Guidance is intended to clarify what clinical projects are appropriate to carry out at the University, and set out procedures for review and oversight of those projects. In addition to the Guidance, there is a flow chart to describe the sequence of review of clinical research projects, and a set of scenarios to illustrate application of the Guidance principles in a variety of contexts, at different Schools.